Provider-Focused Intervention for Maximizing HPV Vaccine Uptake in Young Cancer Survivors

NCT04469569 | Active Not Recruiting

• 2 other identifiers: IRB-3000053051U01CA246567-01A1
• Study Type: interventional
• Target: 5,196
• Locations: 1 country
• Sites: 6

Brief Summary

The focus of this research is on increasing the uptake of the human papillomavirus (HPV) vaccine in young cancer survivors, a vulnerable population at high risk for developing new cancers (such as cervical and anal cancer) caused by persistent HPV infection. An effective vaccine exists that can prevent these cancers, but HPV vaccine uptake is low among young cancer survivors. This research will evaluate the effectiveness and implementation of an evidence-based intervention, adapted for use by healthcare providers in pediatric oncology clinics, to increase the uptake of HPV vaccine among young cancer survivors 9-17 years of age. Results of this research will provide important information that can be used to implement new strategies to increase the uptake of the HPV vaccine among young cancer survivors.

Conditions

Papillomavirus Vaccines

Outcome Measures

Primary Outcomes (1)

• HPV vaccine initiation rates

  Proportion of cancer survivors, age 9-17y and ≥1y post-completion of cancer therapy, who completed a clinic visit (in-person or via telehealth) at one of the participating sites during the intervention year, and who have initiated the HPV vaccine series, as measured via state vaccine registry data

  12 months following implementation of the HPV-PROTECT Intervention.

Secondary Outcomes (2)

• Provider perspectives regarding intervention feasibility, acceptability, appropriateness, fidelity

  Months 11-12 of the Intervention Year (i.e., Year 2 for sites D, E, F and Year 3 for sites A, B, C)]

• Change in provider HPV vaccine-related knowledge and practices

  12 and 24 months [all sites], and 36 months [sites D, E, F only] following implementation of the HPV-PROTECT Intervention)

Other Outcomes (2)

• HPV vaccine series completion rates

  12 and 24 months (all sites), and 36 months (sites D, E, F only) following implementation of the HPV-PROTECT Intervention

• Sustainability of HPV vaccine initiation rates

  24 months (all sites) and 36 months (sites D, E, F only) following implementation of the HPV-PROTECT Intervention

Study Arms (2)

Delayed Intervention

OTHER

Sites randomized to the Delayed Intervention Arm (Sites A, B, C) will be assigned to the control condition in Years 1 and 2, to the HPV-PROTECT intervention in Year 3, and to the sustainability condition in Year 4

Behavioral: HPV-PROTECT

Early Intervention

OTHER

Sites randomized to the Early Intervention Arm (Sites D, E, F) will be assigned to the control condition in Year 1, to the HPV-PROTECT intervention in Year 2, and to the sustainability condition in Years 3 and 4

Behavioral: HPV-PROTECT

Interventions

HPV-PROTECT BEHAVIORAL

HPV-PROTECT is a multicomponent provider-focused intervention specifically tailored for use in pediatric oncology settings, addressing important survivor-specific vaccine issues. The intervention is comprised of three components, i) Provider Communication Training; ii) Assessment and Peer Feedback/ Coaching; and iii) Provider Toolkit. The HPV-PROTECT intervention is designed to increase provider knowledge regarding use of the HPV vaccine in the cancer survivor population, enhance provider skills in delivering brief, compelling HPV vaccine recommendations to parents of young cancer survivors, present ongoing feedback to providers regarding clinic- and provider-level survivor HPV vaccination rates, and decrease barriers to receipt of vaccine by survivors through the provision of Vaccine Action Plans, tailored to local context.

Delayed Intervention; Early Intervention

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HEALTHCARE PROVIDERS (ONCOLOGISTS, ADVANCED PRACTICE PROVIDERS)
• ≥18y of age
• Care for cancer survivors seen in the targeted clinic who are age 9-17y, ≥1y off-therapy, and reside in the state where clinic is located
• Licensed to order vaccines
• Willing to complete surveys and/or interviews
• CHILDHOOD CANCER SURVIVORS
• y of age
• ≥1y following completion of cancer therapy
• Reside in the state where clinic is located
• Receive follow-up care (in person or via telehealth) at the participating sites

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455-0341, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157-0001, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Baylor College of Medicine

Houston, Texas, 77030-3411, United States

Location

Related Publications (1)

• Landier W, Bhatia S, Richman JS, Campos Gonzalez PD, Cherven B, Chollette V, Aye J, Castellino SM, Gramatges MM, Lindemulder S, Russell TB, Turcotte LM, Colditz GA, Gilkey MB, Klosky JL. Implementation of a provider-focused intervention for maximizing human papillomavirus (HPV) vaccine uptake in young cancer survivors receiving follow-up care in pediatric oncology practices: protocol for a cluster-randomized trial of the HPV PROTECT intervention. BMC Pediatr. 2022 Sep 12;22(1):541. doi: 10.1186/s12887-022-03562-1.

  PMID: 36096775 DERIVED

Study Officials

• Wendy Landier, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Cluster-randomized stepped-wedge design with 6 clusters

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 14, 2020
• Study Start: February 1, 2021
• Primary Completion: January 26, 2025
• Study Completion: January 31, 2026
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)